Combination heptavalent vaccine
AssigneeBharat Biotech International Limited
InventorsGopinathan Kuppuswamy, Vijayanand Thiagarajan
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Abstract
The invention provides a stable immunogenic composition for prevention and prophylaxis of infections caused by rota virus, poliomyelitis virus, Haemophilius influenza, Hepatitis B, Corynebacterium diphtheriae, Clostridium tetani, Bordatella pertusis (acellular) in a single combined vaccine. The invention also provides for a bivalent immunogenic composition against rota virus and polio virus. The process of making such compositions of the multivalent antigens are also disclosed. The present invention also relates to the production and use of such vaccines for prophylaxis against the infections mentioned above.
Claims15
A stable heptavalent combination composition consisting of:
- a) inactivated rotavirus strain 116E;
- b) inactivated sabin poliovirus types I, II, and III;
- c) acellular bordatella pertussis antigen;
- d) hepatitis B surface antigen (HBsAg);
- e) haemophilus influenza type b (Hib) antigen conjugated to a carrier protein;
- f) diptheria toxoid (DT);
- g) tetanus toxoid (TT);
- and
- h) one or more excipients;
- wherein any of the each component abovementioned individual antigens is not impaired by the presence of other component antigens;
- wherein the potency value of the heptavalent combination composition is equal or superior than individual component composition;
- and
- wherein the heptavalent combination composition remains stable for at least one year.
A stable heptavalent combination composition consisting of:
- a) inactivated rotavirus strain 116E, wherein the rotavirus comprises an antigenic makeup selected from P[10]G9 and P[11]G10;
- b) D antigens of inactivated sabin poliovirus types I, II, and II;
- c) at least one acellular bordatella pertussis antigen selected from the group of antigens consisting of filamentous hemagglutinin (FHA), pertussis toxoid (PT), and pertactin (P69 or PRN);
- d) hepatitis B surface antigen (HBsAg);
- e) haemophilus influenza type b (Hib) antigen conjugated to a carrier protein, wherein the haemophilus influenza type b (Hib) antigen is capsular polysaccharide polyribosylribitol phosphate (PRP) and the carrier protein is tetanus toxoid (tt);
- f) diptheria toxoid (DT);
- g) tetanus toxoid (TT);
- and
- h) one or more excipients;
- wherein any of the each component abovementioned individual antigens is not impaired by the presence of other component antigens;
- wherein the potency value of the heptavalent combination composition is equal or superior than individual component composition;
- and
- wherein the heptavalent combination composition remains stable for at least one year.
Dependencies are inferred from the claim text.